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The device must only be used for its intended purpose as described in the instruction manual. Using
the appliance for any other purpose invalidates the warranty.
Do not immerse the device in water or other uids.
Always carefully inspect the device for damage before use. Do not attempt to use a defective unit.
Do not dismantle or modify the device in any way.
Do not use the device in the presence of ammable materials and liquids. The device is classied
as an internally-powered, intermittently-operated, ordinary equipment with a disposable type BF
applied part.
Do not replace any part of the device with components or parts other than those supplied by the
manufacturer.
Do not connect the device to any device or system other than the parts supplied with it.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specied or provided by the manufac-
turer of this equipment could result in increased electromagnetic emissions or decreased electro-
magnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and exter-
nal antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including
cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
This device needs special precautions regarding EMC and needs to be installed and put into service
according to the specic instructions for maintaining basic safety and essential performance with
regard to electromagnetic disturbances for the expected service life provided.
The device is intended for use in professional healthcare facility with attending medical sta and
Home healthcare as dened in collateral standard IEC 60601-1-11, as dwelling places where pati-
ents live or are present (excluding professional healthcare facilities mentioned above). Here equip-
ment will be used by non-specialist users and equipment must also be tolerant of poor electrical
supplies.
Charge the PT 100 only using the supplied charger.
Do not attempt to open or remove the cover of the device.
The lithium ion rechargeable battery must not be disassembled, heated above 100 degrees Celsius,
incinerated, or exposed to water.
Be aware of the actuator cable winding around the neck that may lead to injury and strangulation.
Use the device with caution in the following areas:
- Following a laminectomy involving major tissue removal
- In patients susceptible to bleeds
- Over anesthetized areas of impaired skin
Treatment of children should be performed under adult supervision.
In children, avoid use over the epiphyseal growth plate area.
Use caution when removing the actuator patch from the skin after use.
The safety and eectiveness of this device has not been established in patients who are or have
been treated by other medical devices including but not limited to:
- Pacemakers
- Electrical stimulators
- Radiofrequency generators
- Surgical meshes
- Intra-Uterine devices (IUDs)
- Other surgical implants.
When the actuator is warn in a location you are lying on you may experience slight redness of the
skin, which will resolve in a few hours.
Indications for Use
This device is intended to apply ultrasonic energy to generate deep heat within body tissues for the
treatment of selected medical conditions. The low intensity and low frequency ultrasound energy is
eective within a diameter of 20 cm and a depth of approximately 3 cm. The device can therefore be
eective in treating a wound without direct contact with it.
Selected medical conditions for treatment include:
- Pain (including Trigeminal Neuralgia)
- Muscle spasms
- Joint contractures/injury
- Provides improvement in local blood circulation
- Assists in soft tissue healing including post-surgery
- Assists in healing chronic (such as diabetic) wounds
- Improves penetration of topical ointment or gel
Contraindications
The device is prohibited for use in the following cases:
- Patients with cancer and bone metastases under treatment area
- Directly on the eye
- Directly over an open wound
- Directly over ischemic tissues in individuals with vascular disease
- Over the uterus in pregnant patients
- Over bone growth centers until bone growth is complete
Device and controls
1
Charging port
2
Connection for ultrasound actuator
3
On-/O-button
4
Display
5
Actuator pad (front and back side)
6
Ultrasound actuator
7
Battery symbol
8
Treatment cycle number (C1 to C6)
9
Output power in watt
0
Time elapsed in active phase
Scope of supply
Please check rst of all that the device is complete and is not damaged in any way. In case of doubt,
do not use the it and contact your dealer or your service centre.
The following parts are included:
• 1 medisana Painshield Ultrasonic therapy PT 100
• 1 Actuator pad • 1 Charger • 1 Instruction manual • 30 single use adhesive pads
If you notice any transport damage during unpacking, please contact your dealer without delay.
Charging the battery
With fully charged battery, the using time of the device is approx. 6.5 hours.
Charge the battery in accordance with the following guidelines:
Charge the battery only with the supplied charger.
Therapy is not available while the battery is being charged.
Before rst use, remove the device from its packaging and verify that it is fully charged.
Charging the battery:
1. Connect the mini USB plug of the supplied charger to the driver’s charging port
1
.
2. Plug the charger into a wall outlet.
When the driver begins to charge, the screen
lights up brightly and displays the battery icon:
After approximately 1 minute, the screen dims. To refresh the display, briey press the ON/OFF but-
ton
3
. During charging the battery icon lls gradually. Charging takes about 2 hours.
When the battery is fully charged, the battery icon appears full:
Preparation
Remove excess hair, jewellery etc. from the treatment area. Clean the treatment area thoroughly with
soap and water or an alcohol prep pad. Dry the treatment area.
Remove the actuator
6
from its packaging and connect the actuator plug into the driver socket
2
,
making sure to orient the plug correctly in relation to the socket, and make sure the plug is fully inser-
ted and secured
Attach pad
1. Remove the center protective layer from the adhesive of the pad
5
leaving the outer strips at-
tached to insure easy placement.
2. Place the actuator
6
on the exposed adhesive at the center of the patch, with the metal transdu-
cer facing up and the wire aligned with the open notch in the patch.
3. Remove the 2 outer protective liners from the adhesive.
4. Attach the actuator patch to the skin, with the adhesive side down over the area where the pain
is most intense.
Attach pad for trigeminal neuralgia treatment
For trigeminal neuralgia treatment, place the actuator patch next to the cheekbone when the pain is
in the maxillary nerve or next to the lower jaw bone when the pain is in the mandibular nerve. If local
sensitivity makes patch application painful, apply the patch to the forehead on the pain-free side.
Use
1. Make sure that the transducer is in full contact with the skin.
2. Switch on: Press the ON/OFF button
3
until you hear a beep and the company logo appears on
the screen
3. Switch o: Press the ON/OFF button
3
until you hear the shut-o beep.
Hint: Briey pressing the ON/OFF button
3
refreshes the information screen.
The display
In addition to the battery symbol
7
, treatment cycle number
8
, output power in watt
9
and time
elapsed
0
also the company logo, the software version, an error message (see chapter „Errors and
remedying“), „IDLE“ for the idle phase or a 3-second switch-o-countdown may be displayed, depen-
ding on the current operating mode.
Removing the actuator pad
5
Use caution when gently removing the actuator patch from the skin. The adhesive pad
5
is only in-
tended to be used once - dispose of accordingly after use.
Exchange the ultrasound actuator
6
The actuator
6
should be replaced after approx. 30 treatments. To exchange it, proceed as follows:
1. Switch OFF the PainShield driver (to prevent the driver from sounding an alert when it is discon-
nected from the actuator).
2. Disconnect the cable of the actuator
6
from the port
2
.
3. Connect the new actuator cable plug into the driver socket
2
.
Errors and remedying
Error: The device does not turn on.
Remedying: Charge the driver using the supplied charger for 2 hours. If issue is not resolved, contact
the customer service.
Error: The actuator pad is not staying secured to the skin during treatment.
Remedying: Turn o the device. Remove the actuator pad and replace with a new adhesive pad -
these are intended for single use only.
Error: An empty battery icon is displayed on screen.
Remedying: The battery is discharged and requires recharging.
Error: The screen displays a symobl like this:
Remedying: The actuator
6
is damaged or not connected to the driver.
Try and reconnect to driver and if it still fails, replace with new actuator.
Cleaning and maintenance
Before cleaning the unit, make sure it is switched o. Clean the unit with a soft, dry cloth or dis-
infectant medical wipes.
Under no circumstances should you use aggressive detergents, strong brushes, solvents or alco-
hol, as they may damage the surface of the unit.
When cleaning, never immerse the unit in water and make sure that no water gets into the unit.
You should ideally store the device in its original packaging and keep it in a clean, dry place.
Disposal
This product must not be disposed of together with domestic waste.
All users are obliged to hand in all electrical or electronic devices, regardless of whether or
not they contain toxic substances, at a municipal or commercial collection point so that they
can be disposed of in an environmentally acceptable manner. Consult your municipal
authority or your dealer for information about disposal.
Technical specications
Name and model:
Ultrasound frequency:
Voltage / current output:
Rechargeable battery:
Charger:
Active / idle phase:
Automatic switch-o:
Lifespan:
Actuator power:
Beam Non Uniformity Ratio (BNR):
Eective Radiating Area (ERA):
Dimensions approx.:
Weight approx.:
Operating conditions:
Storage conditions:
Item number:
EAN number:
WARNING
Please ensure that polythene packing is kept away from the reach of children! Risk
of suocation!
medisana Painshield Ultrasonic therapy PT 100
90 kHz ± 0.001 kHz
12 V p-p / up to 0.3 A RMS
Lithium-Ion, 3.7V, 1250mAh (charging time approx. 2 h)
Input: 100-240 VAC, 0.4-0.2A, 50/60 Hz
Output: 5 VDC, 1 A
30 min / 30 min = 1 treatment cycle
after 6.5 hours
2 years resp. 400 treatment cycles
0.4 W
6:1
6 cm²
Device: 137 mm (L) x 47 mm (W) x 21 mm (H)
Actuator: 35 mm x 27 mm x 6 mm
Device: 85 g / Actuator: 12 g
Temperature: +5 to +35°C; rel. humidity 10-80%,
Atmospheric pressure 700-1060 hPa
Temperature: +5 to +40°C; rel. humidity 10-80%,
Atmospheric pressure 700-1060 hPa
88346
40 15588 88346 0
In accordance with our policy of continual product improvement, we reserve the right to
make technical and visual changes without notice.
DE/GB
GB
Instruction manual
Painshield Ultrasonic Therapy PT 100
Device and controls
IMPORTANT
Non-observance of these instructions
can result in serious injury or damage
to the device.
WARNING
These warning notes must be observed
to prevent any injury to the user.
CAUTION
These notes must be observed to pre-
vent any damage to the device.
NOTE
These notes give you useful additional
information on the installation or opera-
tion.
Type BF applied part
LOT number
Rated frequency or rated frequency range(s) (Hz)
Beam Non-uniformity Ratio
Part number
Serial number
Eective Radiating
Area Watts (1W = 1000mW)
Power output Continuous Wave
0.4 watts
Square centimeter
Milliwatt per square centimeter
Kilohertz (1 kHz = 1000 Hz)
IP rating per IEC60529
Authorized representative in the EC
Manufacturer
Date of manufacture
Explanation of symbols
1
2
3
4
5
6
EC REP
1282
BNR
P/N
ERA
0.4W
mW/cm
2
kHz
IP22
S/N
W
CW
cm
2
NOTE
If the skin is broken or if the pain is located near a joint, attach the actuator on at
healthy skin area adjacent to the source of pain. Be sure to place the actuator is
within 10cm (4 inches) of the eective area to insure the pain source is within the
treatment area.
NOTE
In rare cases some patients may feel an initial pain increase before experiencing
the benet of the treatment. It is therefore recommended that you proceed gradu-
ally, applying treatment rst for 2-3 hours then gradually increasing up to 6.5 hours
as tolerated. Apply the rst and second treatments while you are awake. You can
subsequently apply treatment during sleep. If you use the device overnight, remove
it on waking up.
7
8
9
0
imported & distributed by:
medisana GmbH, Jagenbergstraße 19, 41468 NEUSS, GERMANY
Read the instruction manual carefully before using this device, es-
pecially the safety instructions, and keep the instruction manual for
future use. Should you give this device to another person, it is vital
that you also pass on these instructions for use.
GB Safety instructions
The current version of this instruction manual can be found under www.medisana.com
Warranty and repair terms
Please contact your dealer or the service centre in case of a claim under the warranty. If you have to
return the unit, please enclose a copy of your receipt and state what the defect is.
The following warranty terms apply:
1. The warranty period for medisana products is three years from date of purchase. In case of a
warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.
2. Defects in material or workmanship will be removed free of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period either for the unit or for the
replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment, e.g. non-observance of the user
instructions.
b. All damage which is due to repairs or tampering by the customer or unauthorised third parties.
c. Damage which has arisen during transport from the manufacturer to the consumer or during
transport to the service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused by the unit are excluded even if the
damage to the unit is accepted as a warranty claim.
NanoVibronix Ltd, 9 Derech Hashalom St, Nesher 36651, Israel.
Tel: +972–4-8200581, Fax: +972-4-8202794, E-mail: info@nanovibronix.com
CEpartner4U BV, Esdoornlaan 13, 3951 DB Maarn, The Netherlands
Tel.: +31.343.442.524, Mobile: +31.6.516.536.26, Fax: +31.343.442.162
Email: oce@CEpartner4U.nl
EC REP
2


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  • Boa tarde. Depois de ligar o aparelho quanto tempo dura o tratamento? O aparelho desliga sozinho?
    Submitted on 2-9-2022 at 15:13

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